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A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Upadacitinib
Placebo for upadacitinib
Topical Corticosteroids (TCS)
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Upadacitinib, Topical Corticosteroids, Atopic Dermatitis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus.
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.
  • Able to tolerate topical corticosteroids for atopic dermatitis lesions.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor.
  • Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study.
  • Requirement of prohibited medications during the study.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Sites / Locations

  • Ichinomiya Municipal Hospital /ID# 205942
  • Nagoya City University Hospital /ID# 207566
  • Central Clinic /ID# 206558
  • Yasumoto Dermatology Clinic /ID# 206480
  • Kiryu Dermatology Clinic /ID# 206044
  • Medical Corporation Matsuo Clinic /ID# 207323
  • Matsuda Tomoko Dermatological Clinic /ID# 206288
  • Higuchi Dermatology Urology Clinic /ID# 206287
  • Central Japan International Medical Center /ID# 205684
  • Kiryu Kosei General Hospital /ID# 206155
  • Gunma University Hospital /ID# 207016
  • Fukuyama City Hospital /ID# 206761
  • Asahikawa Medical University Hospital /ID# 206521
  • Medical Corporation Kato Dermatology Clinic /ID# 206561
  • Kitago Dermatology Clinic /ID# 207025
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
  • Kansai Rosai Hospital /ID# 205918
  • Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
  • Kobe University Hospital /ID# 206200
  • Tokai University Hospital /ID# 206657
  • Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
  • Nippon Medical School Musashi Kosugi Hospital /ID# 206656
  • Yokohama Rosai Hospital /ID# 206648
  • Suizenji Dermatology Clinic /ID# 205871
  • Nagasaki University Hospital /ID# 206118
  • Nagaoka Red Cross Hospital /ID# 209817
  • Isonokami dermatological clinic /ID# 206923
  • Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
  • Shizuoka General Hospital /ID# 207122
  • Mildix Skin Clinic /ID# 206829
  • Yaesu Nihonbashi Skin Clinic /ID# 207125
  • Fukuwa clinic /ID# 206760
  • Hosono Clinic /ID# 205953
  • Nihon University Itabashi Hospital /ID# 206186
  • Mita Dermatology /ID# 206694
  • Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
  • Matsuyama Dermatology /ID# 205998
  • Miu Skin Clinic /ID# 206911
  • Tokyo Rosai Hospital /ID# 205809
  • Tampopo Dermatology Clinic /ID# 207013
  • Naoko Dermatology Clinic /ID# 205334
  • Tachikawa Dermatology Clinic /ID# 206996
  • Toyama Prefectural Central Hospital /ID# 206286

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).

Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).

Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.

Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.

Outcomes

Primary Outcome Measures

Number of participants experiencing adverse events
Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2018
Last Updated
February 27, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03661138
Brief Title
A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Acronym
Rising Up
Official Title
A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Upadacitinib, Topical Corticosteroids, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Upadacitinib Dose A is administered once daily along with Topical Corticosteroids (TCS).
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Upadacitinib Dose B is administered once daily along with Topical Corticosteroids (TCS).
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Placebo administered once daily and TCS followed by Upadacitinib Dose A once daily along with TCS.
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Placebo administered once daily and TCS followed by Upadacitinib Dose B once daily along with TCS.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494
Intervention Description
Upadacitinib is administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo for upadacitinib
Intervention Description
Placebo is administered orally.
Intervention Type
Drug
Intervention Name(s)
Topical Corticosteroids (TCS)
Intervention Description
It is administered concomitantly with upadacitinib or placebo.
Primary Outcome Measure Information:
Title
Number of participants experiencing adverse events
Description
Adverse events are defined as those that began or worsened in severity after the first dose of study drug but within 30 days after the last dose of study drug.
Time Frame
Up to 141 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus. Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis. Able to tolerate topical corticosteroids for atopic dermatitis lesions. Exclusion Criteria: Prior exposure to any Janus kinase (JAK) inhibitor. Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study. Requirement of prohibited medications during the study. Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ichinomiya Municipal Hospital /ID# 205942
City
Ichinomiya-shi
State/Province
Aichi
ZIP/Postal Code
491-8558
Country
Japan
Facility Name
Nagoya City University Hospital /ID# 207566
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Central Clinic /ID# 206558
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-0821
Country
Japan
Facility Name
Yasumoto Dermatology Clinic /ID# 206480
City
Chikushino-shi
State/Province
Fukuoka
ZIP/Postal Code
818-0083
Country
Japan
Facility Name
Kiryu Dermatology Clinic /ID# 206044
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
813-0044
Country
Japan
Facility Name
Medical Corporation Matsuo Clinic /ID# 207323
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-0373
Country
Japan
Facility Name
Matsuda Tomoko Dermatological Clinic /ID# 206288
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8190167
Country
Japan
Facility Name
Higuchi Dermatology Urology Clinic /ID# 206287
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0802
Country
Japan
Facility Name
Central Japan International Medical Center /ID# 205684
City
Minokamo-shi
State/Province
Gifu
ZIP/Postal Code
505-8510
Country
Japan
Facility Name
Kiryu Kosei General Hospital /ID# 206155
City
Kiryu-shi
State/Province
Gunma
ZIP/Postal Code
376-0024
Country
Japan
Facility Name
Gunma University Hospital /ID# 207016
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Fukuyama City Hospital /ID# 206761
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Asahikawa Medical University Hospital /ID# 206521
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Medical Corporation Kato Dermatology Clinic /ID# 206561
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Kitago Dermatology Clinic /ID# 207025
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206519
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Kansai Rosai Hospital /ID# 205918
City
Amagasaki-shi
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki General Medical Center /ID# 206974
City
Amagasaki-shi
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
Kobe University Hospital /ID# 206200
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Tokai University Hospital /ID# 206657
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 206766
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
Nippon Medical School Musashi Kosugi Hospital /ID# 206656
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Yokohama Rosai Hospital /ID# 206648
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Suizenji Dermatology Clinic /ID# 205871
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0950
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 206118
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 209817
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Isonokami dermatological clinic /ID# 206923
City
Daito-shi
State/Province
Osaka
ZIP/Postal Code
574-0046
Country
Japan
Facility Name
Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 209704
City
Neyagawa-shi
State/Province
Osaka
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
Shizuoka General Hospital /ID# 207122
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Mildix Skin Clinic /ID# 206829
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0034
Country
Japan
Facility Name
Yaesu Nihonbashi Skin Clinic /ID# 207125
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa clinic /ID# 206760
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0031
Country
Japan
Facility Name
Hosono Clinic /ID# 205953
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Nihon University Itabashi Hospital /ID# 206186
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Mita Dermatology /ID# 206694
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Medical Corporation Jitai-kai Nakano Dermatology Clinic /ID# 206882
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-0001
Country
Japan
Facility Name
Matsuyama Dermatology /ID# 205998
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
165-0026
Country
Japan
Facility Name
Miu Skin Clinic /ID# 206911
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
114-0052
Country
Japan
Facility Name
Tokyo Rosai Hospital /ID# 205809
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0013
Country
Japan
Facility Name
Tampopo Dermatology Clinic /ID# 207013
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
1430023
Country
Japan
Facility Name
Naoko Dermatology Clinic /ID# 205334
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Tachikawa Dermatology Clinic /ID# 206996
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
1900023
Country
Japan
Facility Name
Toyama Prefectural Central Hospital /ID# 206286
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
36401761
Citation
Katoh N, Ohya Y, Murota H, Ikeda M, Hu X, Ikeda K, Liu J, Sasaki T, Raymundo EM, Teixeira HD, Saeki H. Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2023 Jan;13(1):221-234. doi: 10.1007/s13555-022-00842-7. Epub 2022 Nov 19.
Results Reference
derived
PubMed Identifier
36185549
Citation
Tanaka T, Sasaki T, Ikeda K, Liu J, Tenorio AR, Ohya Y. Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up). World Allergy Organ J. 2022 Sep 13;15(9):100678. doi: 10.1016/j.waojou.2022.100678. eCollection 2022 Sep.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M17-377&Latitude=&Longitude=&LocationName=#additional-resources-section
Description
clinical study report synopsis

Learn more about this trial

A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

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